Overview

Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Santen Inc.
Treatments:
Latanoprost
Ophthalmic Solutions
Criteria
Inclusion Criteria:

- Provided signed, written informed consent.

- 18 years of age and older.

- Diagnosed with primary open-angle glaucoma or ocular hypertension.

- If a subject is a female of childbearing potential she must utilize reliable
contraceptive throughout the study, and must have a negative urine pregnancy test
prior to enrollment into this study.

Exclusion Criteria:

- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing
potential who are not using a reliable method of contraception.

- Presence of any abnormality or significant illness that could be expected to interfere
with the study.